Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05700747
• Other study ID #: 22-437
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: MGH Institute of Health Professions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore whether a structured program can help reduce the challenges of decreased physical functioning and quality of life for participants with multiple myeloma by providing a customized exercise program and fostering engagement in meaningful activities.

The name of the study intervention involved in this study is:

Health Through Activity (HTA) (six-session, rehabilitation exercise regimen)

Description:

The goal of this single arm, pilot study of the Health Through Activity (HTA) rehabilitation intervention for people living with multiple myeloma is to determine if investigators can feasibly deliver the program out of the IMPACT Practice Center at the MGH Institute for Health Professions.

• The six-session 'Health Through Activity' program provides a customized exercise plan and encourages engagement in activities to reduce disability and improve quality of life.

• Study procedures including screening for eligibility, in-clinic visits, questionnaires, and surveys.

• Participation in this research study is expected to last up to 4 months.

It is expected that up to 20 people will take part in this research study.

An internal grant from the Massachusetts General Hospital Institute of Health Professions is providing equipment and staffing for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-=18 years of age

• Diagnosed with multiple myeloma currently receiving maintenance therapy,

• Experiencing disability as indicated by an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"

Exclusion Criteria:

• Bone pain that is either a) new onset or increased in the past month or b) uncontrolled i.e., in the patient's estimation the bone pain "greatly interferes with daily activities"

• History of fracture in the past 12 months without fixation, or

• Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire[29] (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).

• We will also exclude individuals with moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six item cognitive screening tool.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Behavioral:
• Health Through Activity
Six, weekly, customized sessions with licensed physical and occupational therapists.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
MGH Institute of Health Professions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Participant Enrollment	Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility.	At screening
Primary	Assessment Completion Rate	Defined as the number of participants completing each of the three study assessments to number of participants enrolled. A completion rate of 85% will indicate feasibility.	Up to 4 months
Primary	Screening Rate	Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility	Up to 4 months
Primary	Eligibility Rate	Number patients screening positive & eligible / Number screened. Eligibility rate is influenced by how many people in the clinical population are experiencing disability. Based on our pilot study, expected rate to be at least 35%.	Up to 4 months
Secondary	Intervention Completion Rate	Defined as at least 75% of participants complete all six sessions of Health Through Activity (HTA) and if the mean number of sessions is greater than or equal to 4.	Up to 3 months
Secondary	Participant Satisfaction	Assessed by the Satisfaction survey which is a 7-item survey that is rated on a 5-point Likert scale. Any item on the Satisfaction survey that generates a mean score of < 4 will trigger consideration of modification to the HTA program.	Up to 4 months